Evaluation of the safety and pharmacokinetics of FOM-D31 and desmopressin tablet

A randomized, open-label, single-dosing, two-treatment, two-sequence, two-period, crossover study to evaluate the safety and pharmacokinetics of FOM-D31 and desmopressin tablet in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000821

Enrollment

Registered

2013-08-16

Start date

2013-07-26

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Reference drug: Minirin tab. 0.2mg, 2tab., p.o., single-dose Test drug: FOM-D31 (desmopressin 0.2mg), 2EA, p.o., single-dose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy adults between the ages of 20 and 55 years 2. Body weight more than 55 kg, and within 20% of ideal body weight (IBW) IBW (kg)=[height(cm)-100]?0.9 3. Have not any congenital or chronic disease and medical symptoms 4. No clinically relevant abnormalities identified by laboratory test, including Hematology, Blood chemistry, Urinalysis 5. Agreement with written informed consent

Exclusion criteria

Exclusion criteria: 1. Subjects who has clinically relevant current disease or history of liver-biliary teact, kidney, central (peripheral) nervous system, cardiovascular system, blood tumor, urinary system, mental disease, musculoskeletal system, immune system, otorhinolaryngologic system, endocrine system 2. Subjects who has a history of gastrointestinal disease that may affect the bioavailability of the study preparation 3. Subjects who are hypersensitive to desmopressin or other related compounds. 4. SBP =130 mmHg or = 85 mmHg, DBP = 90 mmHg or = 60 mmHg in the sitting position after a 3 minute rest 5. Serum sodium level 10 cigarettes per day for the past 3 months 14. Inappropriate subject for entry into this study in the judgement of the investigator 15. Pregnant or nursing female

Design outcomes

Primary

Measure	Time frame
AUCt and Cmax	—

Secondary

Measure	Time frame
AUCinf, CL/F, t1/2ß, tmax and safety	—

Countries

Korea, Republic of

Contacts

Public ContactJae Woo Kim

Chungnam National University Hospital

Outcome results